Effects of Different Antibiotic Regimens in Preterm Premature Rupture of Membranes
NCT ID: NCT07148622
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2024-10-01
2025-08-10
Brief Summary
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Detailed Description
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Methods: A total of 40 pregnant women diagnosed with PPROM after the 34th week of gestation were included in the study and randomly divided into two equal groups. Group-1: Sulbactam + ampicillin, azithromycin, and amoxicillin. Group-2: Ceftriaxone, clarithromycin, and amoxicillin. For all cases, obstetric history, time of delivery, latency period, infection markers, neonatal birth weight, APGAR scores, NICU requirement and length of stay, type of delivery and maternal complications were recorded.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Antibiotic regimen 1
Antibiotic regimen 1: sulbactam + ampicillin + azithromycin
For the first 48 hours, 4×2 g IV sulbactam + ampicillin, 1 g oral azithromycin on day 1, and from days 3-7, 3×500 mg oral amoxicillin
Antibiotic regimen 2
Antibiotic regimen 2: ceftriaxone + clarithromycin + amoxicillin
For the first 48 hours, 1×1 g IV ceftriaxone + 2×500 mg oral clarithromycin, and from day 3 onwards, 3×500 mg oral amoxicillin + 2×500 mg oral clarithromycin.
Interventions
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Antibiotic regimen 1: sulbactam + ampicillin + azithromycin
For the first 48 hours, 4×2 g IV sulbactam + ampicillin, 1 g oral azithromycin on day 1, and from days 3-7, 3×500 mg oral amoxicillin
Antibiotic regimen 2: ceftriaxone + clarithromycin + amoxicillin
For the first 48 hours, 1×1 g IV ceftriaxone + 2×500 mg oral clarithromycin, and from day 3 onwards, 3×500 mg oral amoxicillin + 2×500 mg oral clarithromycin.
Eligibility Criteria
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Inclusion Criteria
* PPROM after 34 weeks of gestation
Exclusion Criteria
* Preeclampsia, gestational or pregestational diabetes mellitus,
* Multiple pregnancies,
* Chorioamnionitis, placental abruption, cord prolapse, fetal distress, or other complicated pregnancies.
* Maternal immunodeficiency
* The presence of other infections requiring antibiotic therapy, antenatal corticosteroid use, chronic diseases,
* Unwillingness to participate and sign the detailed informed consent form
18 Years
40 Years
FEMALE
No
Sponsors
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Yuzuncu Yıl University
OTHER
Responsible Party
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Onur Karaaslan
YuzuncuYıl
Locations
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Van Yuzuncu Yil University
Van, , Turkey (Türkiye)
Countries
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References
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Lee J, Romero R, Kim SM, Chaemsaithong P, Yoon BH. A new antibiotic regimen treats and prevents intra-amniotic inflammation/infection in patients with preterm PROM. J Matern Fetal Neonatal Med. 2016 Sep;29(17):2727-37. doi: 10.3109/14767058.2015.1103729. Epub 2015 Dec 2.
Sgayer I, Francis YN, Miron D, Shprits E, Sheffer VF, Rechnitzer H, Lowenstein L, Wolf MF. Compared perinatal outcomes of two prophylactic antibiotic regimens for preterm premature rupture of membranes: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 May;5(5):100900. doi: 10.1016/j.ajogmf.2023.100900. Epub 2023 Feb 13.
Other Identifiers
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VYYU-KHD-OK-11
Identifier Type: -
Identifier Source: org_study_id